Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury in Hemodialysis Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the number of left ventricular segments undergoing a greater than 20% reduction in longitudinal strain as detected by echocardiogram
研究概览
简要总结
The goal of this study is to determine what happens to the heart muscle contraction when people cycle before their hemodialysis treatment. Will pre-dialysis exercise protect the heart from a decrease in pumping of the heart muscle (called stunning) that can happen during hemodialysis. We will study whether pre-dialysis exercise decreases heart stunning, decreases the number and severity of symptoms commonly associated with hemodialysis, and other outcomes
详细描述
This will be the first randomized crossover-controlled trial with two experimental conditions assessing the impact of exercise preconditioning in the HD population. If proven effective exercise preconditioning could be developed as a therapeutic option to reduce rates of heart failure in the dialysis population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must be on chronic hemodialysis for at least 3 months
- •age 18 years or older
- •willing and able to provide informed consent
- •assessed to be safe and able to exercise by unit HD Nephrologist
排除标准
- •regular vigorous exercise outside of hemodialysis
- •over 79 years of age
- •intradialytic exercise < 3 months
- •poor echogenicity
- •acute coronary syndrome in the past 3 months
- •unstable arrhythmia/angina
- •shortness of breath at rest or with minimal activity
- •symptomatic hypoglycemia (>2x/week in the week prior to enrolment)
研究组 & 干预措施
Randomization Order 1
Participants will be randomized into one of the two groups indicating the order in which they will receive the exercise intervention.
Randomization Order 1 will receive the exercise treatment on the first day of the first week of the study. The other three days without exercise will consist of standard dialysis sessions with study procedures.
干预措施: Intradialytic Cycling (Other)
Randomization Order 2
Participants will be randomized into one of the two groups indicating the order in which they will receive the exercise intervention.
Randomization Order 2 will receive the exercise treatment on the first day of the fourth week of the study. The other three days without exercise will consist of standard dialysis sessions with study procedures.
干预措施: Intradialytic Cycling (Other)
结局指标
主要结局
Change in the number of left ventricular segments undergoing a greater than 20% reduction in longitudinal strain as detected by echocardiogram
时间窗: week 1 to week 4
An echocardiogram will be completed pre-hemodialysis (HD) treatment and at peak hemodynamic stress (30 min before the end of HD treatment) at each of the four study sessions. Images will be captured in the left lateral position and standard apical 4, 2, and 3 chamber views will be recorded for analysis using automated speckle-tracking software (EchoPac, GE Healthcare)
次要结局
- Evaluate potential targets of preconditioning by exercise-induced cardio protection by focusing on hemodynamics (Blood Pressure)(week 1 to week 4)
- Evaluate potential targets of preconditioning by exercise-induced cardio protection focusing on hemodynamics (CV Insight Monitoring),(week 1 to week 4)
- Evaluate potential targets of preconditioning by exercise-induced cardioprotection, focusing on hemodynamics (Finapres)(week 1 to week 4)
- Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on blood markers(week 1 to week 4)
- Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on erythrocyte deformability(week 1 to week 4)
- Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on endothelial function(week 1 to week 4)
- Evaluate potential targets of preconditioning by exercise-induced cardioprotection, focusing on proteomic analysis.(week 1 to week 4)
研究者
Chris McIntyre
Nephrologist, Professor of Medicine, Medical Biophysics and Paediatrics
London Health Sciences Centre